The highly controversial and now notorious clinical guidelines table, which arbitrarily set the age criterion of 75 years for assigning transcatheter aortic valve implantation (TAVI) or surgery for low-risk aortic stenosis, also recommended favoring surgery in patients with correctable concomitant conditions, such as coronary artery disease. This was nuanced with more flexible treatment indications based on the surgical or interventional approach. In surgery, treatment was mandated for all lesions >70% (Class I) and for 50-70% (Class IIa) lesions when concomitant, whereas interventionists were only required to treat proximal lesions >70% (Class IIa).
Due to a lack of updates, current guidelines are now outdated, leading many to disregard them, resulting in disorderly patient assignment to invasive procedures in medical-surgical or Heart-Team sessions, increasingly deviating from ethical and scientific rigor. Concomitant coronary artery disease in aortic valve disease is common, with many patients now relegated to TAVI procedures under the justification of balancing supply and demand by correcting the increased afterload condition. However, this leaves coronary artery disease unresolved, relegated to optimal medical treatment with no prognostic benefit in multivessel disease.
The study by Sakurai et al., conducted by a Japanese group and marked by cultural aspects that emphasize scientific rigor, provides valuable insights. The team conducted a meta-analysis comparing outcomes in cohorts from major studies that contrast TAVI versus surgery, selecting patients who received concomitant revascularization (simultaneous in surgery and sequential or simultaneous in intervention). This should alert us that, given the selected nature of clinical trial cohorts, randomization effects are lost, and the studies thus become purely observational prospective studies.
Notable aspects of the meta-analysis include a comprehensive database search with a declared strategy, strict bias analysis through multiple methods, and transparent reporting of data and potential biases in the appendices.
Studies comparing TAVI and surgical aortic valve replacement (SAVR) published until November 2010 were included, with selected cohorts receiving revascularization (percutaneous coronary intervention [PCI] vs. coronary artery bypass grafting [CABG]), suggesting that raw data from original studies were provided in some cases. MEDLINE, EMBASE, and Cochrane databases were analyzed, ultimately including 2 randomized studies (NOTION and PARTNER 3) and 6 observational ones. This encompassed 104220 patients with a weighted mean follow-up of 30.2 months. TAVI + PCI was associated with higher all-cause mortality (HR = 1.35; p = 0.003), the need for additional revascularization during follow-up (HR = 4.14; p = 0.001), a higher need for pacemaker implantation within 30 days post-procedure (OR = 3.79; p = 0.002), and vascular complications related to valve and/or coronary access (OR = 6.97; p = 0.004). Conversely, TAVI + PCI was associated with lower 30-day renal failure rates (OR = 0.32; p = 0.0001), while 30-day rehospitalization rates, stroke during 30-day and follow-up, 30-day mortality, 30-day myocardial infarction, and major post-procedural bleeding were comparable to those observed in SAVR + CABG.
No significant publication bias was detected for the observational cohort-based meta-analysis, nor was there a change in trend for the effect sizes in the previously reported outcomes upon sensitivity analysis. The authors conclude that in patients with aortic stenosis and concomitant coronary artery disease, TAVI + PCI is associated with higher mid-term mortality compared to the pathology’s treatment with SAVR + CABG. The Heart-Team must heed this evidence in patient assignment to the best treatment alternative, especially in those with acceptable surgical risk.
COMMENTARY:
The study under review is highly relevant, and its findings should be taken into account in future recommendations or clinical guidelines. Although coronary artery disease and aortic stenosis representation in clinical trials is lower than in real life, registries report that 38% of aortic stenosis patients require concomitant revascularization. Not surprisingly, two age-related diseases with an atherosclerotic basis frequently coexist.
The study underscores the superior results of the surgical option, with no significant procedural penalties, achieving up to 30% more survival rates and reducing major cardiovascular events to one-third or one-fourth in future instances. As previously discussed, patients without revascularized coronary disease will have a poor prognosis if TAVI is viewed as a panacea. Patients have the right to have multiple diseases, even cardiac, and we, as healthcare professionals, are obliged to treat all their conditions using the best available means.
When coronary disease is not treated simultaneously, as is the case with surgery, additional morbidity arises, notably in repeated procedures, which increase the risk of vascular complications by more than sixfold. Furthermore, for cases lacking planned revascularization, it is widely known that managing coronary disease in the presence of an implanted TAVI is challenging. In fact, other studies highlight untreated coronary disease as an independent predictor of post-TAVI mortality. While not all patients with concomitant coronary disease and aortic stenosis are low-risk, expected survival must guide treatment options beyond the arbitrary age criterion, a criterion more akin to market research than solid scientific foundation. Lastly, some outcomes shown by the TAVI + PCI approach may be influenced by incomplete revascularization. However, it has been demonstrated that compared to non-revascularization, results are practically equivalent, at least for functionally significant lesions.
For now, it seems that the status quo persists, as exemplary studies like this often fail to impact the established paradigm. Nevertheless, results as clear as these, shown with full transparency, should not be forgotten; instead, they should transcend recommendations documents and, ultimately, clinical practice. The literature flood of commercial evidence is a trend, where quantity does not necessarily equate to quality, and it buries significant findings like those in this study. Our mission is to unearth these findings and ensure they gain the weight they deserve.
REFERENCE:
Sakurai Y, Yokoyama Y, Fukuhara S, Takagi H, Kuno T. Complete transcatheter versus surgical approach to aortic stenosis with coronary artery disease: A systematic review and meta-analysis. J Thorac Cardiovasc Surg. 2024 Apr;167(4):1305-1313.e9. doi: 10.1016/j.jtcvs.2022.08.006.
